(190 days)
Not Found
No
The device description focuses on radiofrequency energy delivery and waveform selection via manual controls, with no mention of AI or ML capabilities.
Yes
The device is described as an "Electrosurgery Generator" used for "resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels," and for "cutting, coagulation, and hemostasis" in various medical and surgical procedures. These functions serve to treat medical conditions and restore health, specifically by altering tissue.
No
Explanation: The device description and intended use clearly state that the SurgiMax / SurgiMax Plus is used for surgical procedures such as resection, ablation, coagulation, and hemostasis, not for diagnosing medical conditions.
No
The device description clearly describes a hardware device (electrosurgery generator) that produces radiofrequency energy for surgical procedures. It mentions front panel controls, displays, foot/hand switches, and electrodes, all indicative of a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are all related to surgical procedures performed directly on the patient's body (resection, ablation, coagulation, cutting, hemostasis). IVDs are used to examine specimens taken from the body (blood, urine, tissue samples, etc.) to provide information about a patient's health status.
- Device Description: The device is described as a source of high radiofrequency energy used for surgical procedures. This is consistent with an electrosurgery generator, not an IVD.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the SurgiMax / SurgiMax Plus is a surgical device, specifically an electrosurgery generator, and not an IVD.
N/A
Intended Use / Indications for Use
For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.
Cutting
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty.
Blended Cutting and Coagulation
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.
Hemostasis and Nonablative Coagulation
Control of bleeding, Epilation, Telangiectasia
Bipolar
Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatop!asty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The SurgiMax / SurgiMax Plus is a compact source of high radiofrequency energy employed for a variety of procedures. This action is achieved by front panel selection of waveforms and power levels. The subject device can be used with monopolar or bipolar devices. The energy is used for cutting, coagulation, and hemostasis.
The SurgiMax / SurgiMax Plus Electrosurgery Generator is a compact source of high radio-frequency RF energy to be employed for a variety of radiosurgery procedures. This action is achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps, which give the operator feedback of status.
Power level for each mode is indicated by front panel digital displays; which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are offered.
This device is designed to comply with international safety standards including applicable IEC series electrical safety standards.
The power output in the CW (Cut) mode is 120 watts into (500 ohms) a matched load. The output frequency is maintained at 4.0 MHz +/- 400Hz over all service and loading conditions including short and open for monopolar mode.
Three output waveforms are provided:
CW CUT - Continuous wave output with average power equal to the maximum with no deliberate modulation.
CUT / COAG – Deeply modulated envelope with average to peak power ratio approximately 50%. Modulation occurring at 75 Hz rate.
HEMO - Deeply modulated wave with average to peak ratio approximately 50%. Modulation occurring at 75 Hz rate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, blood vessels, knee, shoulder, ankle, elbow, hip, wrist, palatal, ear (myringotomy), turbinate, skin, biopsy sites, cysts, abscesses, tumors, keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, telangiectasia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing and comparison between the subject device and predicate device demonstrate equivalent performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
K100390
510 (k) Summary
Date Prepared
AUG 2 5 2010
Revised August 19, 2010
Submitter's Information
Joseph Azary c/o Orchid Design 80 Shelton Technology Center Shelton, CT 06484 Tel: (203) 922-0105 Fax: (203) 922-0130 Email: joseph.azary@orchid-orthopedics.com
Manufacturer/Sponsor: Elliquence LLC 3333 Royal Avenue Oceanside, NY 11572
Establishment Registration for Elliquence LLC Inc. is 3007024186.
Device Trade Or Proprietary Names
Possible device trade names are:
- . SurgiMax
- . SurgiMax Plus
Device Common, Usual, or Classification Names
Electrosurgical Unit and Accessories, Electrosurgical Cutting and Coagulation and Accessories
Classification Panel
Classification of this device would fall under the responsibility of the Division of General, Restorative, and Neurological Devices.
Class
Classification: Class 2 Product Code: GEI, 21 CFR 878.4400
1
Description of the Device
The SurgiMax / SurgiMax Plus is a compact source of high radiofrequency energy employed for a variety of procedures. This action is achieved by front panel selection of waveforms and power levels. The subject device can be used with monopolar or bipolar devices. The energy is used for cutting, coagulation, and hemostasis.
The SurgiMax / SurgiMax Plus Electrosurgery Generator is a compact source of high radio-frequency RF energy to be employed for a variety of radiosurgery procedures. This action is achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps, which give the operator feedback of status.
Power level for each mode is indicated by front panel digital displays; which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are offered.
This device is designed to comply with international safety standards including applicable IEC series electrical safety standards.
The power output in the CW (Cut) mode is 120 watts into (500 ohms) a matched load. The output frequency is maintained at 4.0 MHz +/- 400Hz over all service and loading conditions including short and open for monopolar mode.
Three output waveforms are provided:
CW CUT - Continuous wave output with average power equal to the maximum with no deliberate modulation.
CUT / COAG – Deeply modulated envelope with average to peak power ratio approximately 50%. Modulation occurring at 75 Hz rate.
HEMO - Deeply modulated wave with average to peak ratio approximately 50%. Modulation occurring at 75 Hz rate.
2
Specifications:
o
Nominal Line Voltage:
240/220/120/100 V
Input Current at Max Output Power:
240/230/220V: 1.5A 120/100V: 3.3A
Width and Height:
।
9.25" x 5" x 13.25" (23.5cm x 1.7cm x 33.7cm)
Weight:
20 lbs (9.07 kg)
Output Characteristics:
| Output Characteristics: | |||
|---|---|---|---|
| Mode | Output Wave- | ||
| form | Max Power | Activation | |
| CUT | 4.0 MHz CW | ||
| sinusoid | 120 W at 500 | ||
| Ohms | Footswitch or | ||
| fingerswitch | |||
| CUT/COAG | 4.0 MHz with | ||
| rectified full | |||
| wave envelope | 90 W at 500 | ||
| Ohms | Footswitch or | ||
| fingerswitch | |||
| HEMO | 4.0 MHz with | ||
| square wave | |||
| rectified | |||
| envelope | 60 W at 500 | ||
| Ohms | Footswitch or | ||
| fingerswitch | |||
| BIPOLAR | |||
| HEMO | 1.7 MHz with | ||
| square wave | |||
| rectified | |||
| envelope | 40W at 200 | ||
| Ohms | Footswitch | ||
| BIPOLAR | |||
| TURBO | 1.7 MHz with | ||
| CW sinusoid | 120W at 200 | ||
| Ohms | Footswitch |
Intended Use [21 CFR 807.92(a)(5)]
3
Orthopedic, arthroscopic, spinal, and neurosurgical
For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.
Cutting
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, turnors, cosmetic repairs, development of skin flaps, Blepharoplasty.
Blended Cutting and Coagulation
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.
Hemostasis and Nonablative Coagulation
Control of bleeding, Epilation, Telangiectasia
Bipolar
Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.
Technological Characteristics [21 CFR 807.92(a)(6)]
Elliquence LLC believes that the subject device has the identical technological characteristics of the predicate device. This include outputs, performance, software, electronics, and indications for use. We believe the subject device is substantially equivalent to the predicate device.
Performance Data [21 CFR 807.92(b)(1)]
The Ellman SurgiMax / SurgiMax Plus complies with IEC 60601-2-2. Non-clinical testing and comparison between the subject device and predicate device demonstrate equivalent performance.
Predicate Device [21 CFR 807.92(a)(3)]
The predicate devices are listed as follows:
4
Ellman Surgimax - K061174 .
The subject device and predicate device have identical indications for use, waveforms, functionality with bipolar and monopolar devices, frequency, maximum power, weight, and power adjustment. The electronics and software in the subject device is the same identical electronics and software in the predicate device. The outputs and performance characteristics are identical as the electronics and software have not changed.
The differences are:
- . Cosmetic differences to the outer case and faceplate
- . Difference in product name (Elliquence Surgimax or Elliquence Surgimax Plus versus Ellman Surgimax)
- Labeling changed to reflect the company name and the image to reflect the cosmetic differences. .
These differences do not affect safety or performance as they are cosmetic or aesthetic in nature.
Conclusion [21 CFR 807.92(b)(3)]
We believe the differences between the subject device and predicate device are minor and conclude that the subject devices are as safe and effective as the predicate devices.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Elliquence, LLC. % Orchid Design Mr. Joseph Azary 80 Shelton Technology Center Shelton, Connecticut 06484
AUG 2 5 2010
Re: K100390
Trade Name: Eliquence Surgimax / Surgimax Plus Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 20, 2010 Received: July 22, 2010
Dear Mr. Azary: .
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
6
Page 2 - Mr. Joseph Azary
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm/15809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Coopliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolloffred number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/medicaldevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark M Millerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known):
Device Name: Elliquence Surgimax / Surgimax Plus
Indications For Use:
Orthopedic, arthroscopic, spinal, and neurosurgical
For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.
Cutting
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty.
Blended Cutting and Coagulation
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.
Hemostasis and Nonablative Coagulation Control of bleeding, Epilation, Telangiectasia
Bipolar
Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatop!asty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
1
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number